Info Service on Health Issues (May13/08)
Draft text on neglected tropical diseases favours industry
Geneva, 23 May (K M Gopakumar) – Concerns have surfaced that the draft resolution on neglected tropical diseases at the ongoing World Health Assembly session promotes the interests of pharmaceutical multinational corporations.
The central role given to partnerships with industry that focus on medicines donation, could undermine a long-term systemic solution to the South’s struggle to address the burden of those diseases.
The WHA will consider a report and the annexed resolution on Friday, 24 May at the Committee A. The draft text was approved by the 132th session of the WHO Executive Board and contains nine preambular paragraphs and 3 operational paragraphs. Its primary objective is to obtain political endorsement of WHO’s Roadmap titled “Accelerating Work to overcome the Global Impact of Neglected Tropical Disease” and the “London Declaration on Neglected Tropical Diseases”.
According to the report of the Secretariat on neglected tropical diseases (NTD) (A66/20), “in 2011 WHO and its Strategic and Technical Advisory Group for Neglected Tropical Diseases drew up the roadmap to accelerate work on neglected tropical diseases”. It sets targets for the eradication of dracunculiasis (by 2015) and yaws (by 2020). It also sets six targets for the elimination of five NTD by 2015, and 10 elimination targets either globally or in selected geographical areas for nine NTD by 2020. Further, the roadmap also has targets for intensified control of dengue, Buruli ulcer, cutaneous leishmaniasis, selected zoonoses and helminthiases.
The roadmap recommends five public health measures for the prevention, control, elimination, and eradication of NTD: preventive chemotherapy; intensified case-management; effective vector control; the provision of safe drinking-water, basic sanitation and hygiene; and involvement of veterinary public health. The sixth area of intervention proposed by the roadmap is in the area of capacity strengthening.
The purpose of the roadmap is to guide implementation of the policies and strategies set out in the “Global Plan to combat neglected tropical diseases 2008–2015” and developed in the document “Working to overcome the global impact of neglected tropical diseases”.
Following the publication of the roadmap, in 2012 a conference attended by the heads of global health organizations, donors, politicians and pharmaceutical industry leaders endorsed the London Declaration on Neglected Tropical Diseases. The Declaration has the following elements: (a) to sustain, expand and extend programmes that ensure the necessary supply of medicines and other interventions; (b) to advance research and development through partnerships and provision of funding to find next-generation treatments and interventions; (c) to enhance collaboration and coordination at national and international levels; (d) to enable adequate funding with countries endemic for the neglected tropical diseases to implement programmes necessary to achieve these goals, supported by strong and committed health systems at the national level; and (e) to provide technical support, tools and resources to countries endemic for these diseases to evaluate and monitor those programmes.
Preambular paragraph 3 (PP3) of the resolution notes “the WHO’s roadmap to accelerate the work to overcome the global impact of neglected tropical diseases and the subsequent London Declaration on Neglected Tropical Diseases endorsed by a community of partners.”
Further, operational paragraph 1(2) urges WHO Member States “to expand and implement interventions against neglected tropical diseases in order to reach the targets agreed by WHO and its partners in the London Declaration on Neglected Tropical Diseases and set out in WHO’s roadmap for accelerating work to overcome the global impact of neglected tropical diseases by…”
Thus the main purpose of the resolution is to legitimize and mainstream WHO’s partnership approach to overcome the global impact of NTD.
Both the roadmap and the declaration use the partnership as the vehicle of programme implementation, with the pharmaceutical MNCs as one of the leading partners. The resolution aims to obtain the political endorsement form Member States and to legitimize such partnership.
The NTD roadmap clearly acknowledges the role of pharmaceutical MNCs and depends upon the drug donations from pharmaceutical MNCs to provide treatment. The roadmap contains the following references to the pharmaceutical industry.
Regarding the success of the roadmap it states: “The roadmap’s destination can be reached only if two established, interconnected routes are followed”. The first route is to continue to provide guidance and technical insight to policy makers and programme managers in governments seeking to prevent, control, eliminate and eradicate the NTDs that are endemic in their countries.”
The second interconnected route according to the roadmap: “The other route is to continue to encourage the community of partners – including donors, pharmaceutical companies, agencies, nongovernmental organizations (NGOs), philanthropists and universities – to maintain and increase their commitments to overcoming NTDs”.
Further, the roadmap states that the international experts who serve on the Strategic and Technical Advisory Group for NTD which approved the roadmap clearly recognizes the role of the pharmaceutical MNCs and states:
· In addition to donors, agencies, NGOs and others, positive outcomes from working with the pharmaceutical companies have helped millions of people to receive free regular treatment for Chagas disease, human African trypanosomiasis, fascioliasis and other foodborne trematodiases, leprosy, lymphatic filariasis, onchocerciasis, schistosomiasis, soil-transmitted helminthiases and trachoma.
· WHO/NTD has established an effective, transparent and respected relationship with a number of pharmaceutical companies and has contributed to mobilizing much needed resources as part of the industry’s corporate social responsibility.
· Expertise has been acquired in the complex process of procurement, quality assurance and improved access to medicines, again reflecting the important relationship between WHO/NTD and the pharmaceutical companies.
The roadmap further anchors the drug donation program as one of the important modes of providing access to medicines (WHO had entered into such an Agreement with the pharmaceutical MNCs). The roadmap states that recent renewal of these agreements would ensure donations of medicines and financial support until the end of 2017.
According to the road map the following pharmaceutical companies are the major donors of medicines: GlaxoSmithKline Kline (Albendazole), Gilead (AmBisome), Pfizer (Azithromycine), Eisai Co. Ltd (DEC), Sanofi (Eflornithine), Merck & Co (Ivermectin); Novartis (Rifampacin, clofazimine and dapsone), Johnson & Johnson (Mebendazole), Sanofi(Melarsprol), Bayer (Pentamidine), Sanofi (Pentamidine), Merck KGaA ( Praziquantel), Bayer ( Suramin), Novartis ( Triclabendazole).
Thus there are 11 companies listed in the roadmap. Except for Gilead all others seem to provide the medicines as donation and Gilead provides it through a WHO concessional price.
In 2012, as a follow up to the publication of the roadmap, the partnership was launched through a conference in London which adopted the declaration. According to the WHO website, “the Roadmap that lays out the vision for ending the misery caused by neglected tropical diseases has inspired public and private partners to unite in the fight against some of the most devastating diseases”. The London Conference witnessed “Major pharmaceutical companies, the Bill & Melinda Gates Foundation, the governments of the United States, United Kingdom and United Arab Emirates and the World Bank announced measures to support WHO in sustaining progress achieved as well as give a push to accelerate the control, elimination and eradication of these diseases”.
As per the WHO website the major measures that came out of the conference include: “sustaining or expanding current medicine donation programmes to meet demand through 2020; providing more than US$785 million to support elimination efforts; strengthening drug distribution and implementation programmes. sharing expertise and compounds to promote research and development of new medicines.”
Apart form the Bill & Melinda Gates Foundation and the World Bank the following pharmaceutical MNCs also endorsed the declaration: Abbott, Astra Zeneca, Bayer, Becton Dickinson, Bristol Mayors Squibb, Gilead, Glaxo SmithKline, Johnson and Johnson, Merck, Novartis , Pfizer and Sanofi.
According to the roadmap its purpose is to guide implementation of the policies and strategies set out in the “Global Plan to combat neglected tropical diseases 2008–2015.” (http://whqlibdoc.who.int/hq/2007/who_cds_ntd_2007.3_eng.pdf)
However, the roadmap diluted the implementation plan contained in the Global Plan in order to make it palatable for the pharmaceutical MNCs.
The Global Plan identified an urgent need for diagnostic tools, medicines and pesticides and development of more effective medicines and insecticides are the key challenges. It clearly states: “Current control strategies for some NTDs that belong to the tool-deficient category rely on imperfect tools. Diagnostic tools, medicines and pesticides are costly and difficult to manage. Using the currently available tools, sustainable control or elimination of the diseases remains an unattainable objective. This reality points to an urgent need to develop simple and safe control tools that can be integrated into health systems in resource-limited settings”.
However, the task of development of new tools is identified within the public private partnership, while the Global Plan clearly puts WHO in the leading role: “WHO should play a leadership role in the introduction of innovative tools and in making them available and accessible to populations in need”.
Further, it identified access to innovation as one of the strategic areas for action.: “access to innovation is an integral part of control activities because it allows adaptation of NTD control strategies. ‘Access to innovation’ refers to a process that facilitates and expedites the development of new key tools, and ensures their quick implementation at field level”.
The roadmap is completely silent on the innovation of new products. The five areas identified for intervention do not include access and innovation.
The London Declaration states that one of the commitments is to “advance research and development through partnerships and provision of funding to find next-generation treatments and interventions”. However, the Declaration is silent on the R&D model to be followed in this area. Since the publication of the WHO Report of the Commission on Intellectual Property Public Health and Innovation (CIPIH) there is ample evidence existing within WHO that the mainstream approaches to R&D based on the intellectual property protection model does not work in the area of NTD.
The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property adopted by Member States clearly acknowledges the need for alternative models based on delinking of the cost of R&D from the prices of medicines through an open innovation approach. However, the London Declaration is silent on this.
It is also not clear from the documents viz. roadmap, Declaration and draft resolution, whether the medicine needs are to be met exclusively through drug donation or whether procurement on a commercial basis is also carried out under the initiative. If there is commercial procurement, whether the non-partners, including generic companies, are allowed to participate in the procurement program.
Operational paragraph 2.3 of the draft resolution calls upon WHO’s international partners, including intergovernmental, international and nongovernmental organizations, financing bodies, academic and research institutions, civil society and the private sector “to encourage initiatives for the discovery and development of new diagnostics, medicines and pesticides, and to support operational research to increase the efficiency and cost-effectiveness of interventions, taking into account the global strategy and plan of action on public health, innovation and intellectual property”.
The 132nd session of the Executive Board of WHO while approving the draft resolution for WHA consideration added the following words: “taking into account the global strategy and plan of action on public health, innovation and intellectual property”. However, it is clearly silent on the principles of open innovation and delinking of cost of R&D as a guiding principle.
The Report of the Consultative Expert Working Group on R&D Coordination and finance (CEWG) recommended certain guiding principles for R&D. The Report recommends an “open knowledge innovation” approach to R&D. It further defines this approach and states: “We characterize these as ‘open knowledge innovation’, and define this as research and innovation that generates the knowledge which is free to use without legal or contractual restrictions”.
Similarly operational paragraph 3(4) requests the WHO Director-General to encourage and support initiatives to discover and obtain new diagnostic tools, medicines and insecticides, and to support operational research to increase the efficacy and cost effective intervention”. The resolution is not requesting the WHO DG to advocate open knowledge innovation to achieve the objectives of delinking of the cost of R&D from the price of the product.
Stressing the need for R&D to develop new tools including diagnostics Bernard Pecoul, Executive Director of Drugs for Neglected Diseases (DNDI) , one of the signatories of the declaration wrote in PLoS NTD “'Although tools exist to control, or in some cases even eliminate, NTDs, for many of these diseases the tools and implementation strategies available are suboptimal, incomplete, or inadequate to sustain elimination efforts. Consequently, substantial investments in R&D are ur- gently needed to develop new-generation control tools and strategies for their improved use and implementation.”
Under the list of commitments of the declaration DNDI is to get access to the compound libraries of Abbott, AstraZeneca, Novartis, Pfizer, GlaxoSmithKline and Eisai to develop new medicines. However, one of the sources told the author “there should be initiatives from the WHO Secretariat and Member Sates to ensure that these commitments from the pharmaceutical companies are met in transparent timely manner”.
Thus the NTD initiative and the resolution are widely viewed as a pharmaceutical MNCs agenda to neutralize the implementation of CEWG recommendations.
Some experts also point out that draft NTD resolution failed to make the linkage with other existing initiatives within the WHO like the Tropical Drug Research (TDR), the Special Programme for Research and Training in Tropical Disease jointly set up by the United Nations Children's Fund (UNICEF), the United Nations Development Programme (UNDP), the World Bank and WHO in 1975.
Similarly the roadmap identifies safe water and sanitation for intervention. The Global Plan to combat neglected tropical diseases 2008–2015 identified pro-poor polices as a key principle for intervention. It states: “The fight against NTDs should form an integral part of pro-poor policies. The introduction of basic public health measures, such as access to clean water and sanitation as well as health education, would significantly reduce the burden of a number of NTDs and other infectious diseases”.
The political declaration adopted at the Rio Conference on Social Determinants of Health clearly states: “Based on the experiences shared at this Conference, we express our political will to make health equity a national, regional and global goal and to address current challenges, such as eradicating hunger and poverty, ensuring food and nutritional security, access to safe drinking water and sanitation, employment and decent work and social protection, protecting environments and delivering equitable economic growth, through resolute action on social determinants of health across all sectors and at all levels.”
However, the roadmap, the Declaration and the draft resolution are silent on the social determinants aspects of the intervention. The resolution does not establish any linkage between the social determinants aspects of NTDs.
Another important missing link is the linkage of NTD resolution with the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA). The aim of the GSPOA is “to promote new thinking on innovation and access to medicines and, based on the recommendations of the report of the Commission on Intellectual Property Rights, Innovation and Public Health, provide a medium-term framework for securing an enhanced and sustainable basis for needs-driven essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area.”
Element 5.3 of the GSPOA clearly mentions the delinking of the costs of research and development and the price of health products.
the monitoring matrices identified the following action on Element
The resolution provides only lip service mentioning in the preamble without any corresponding operational paragraphs except a reference at Operational Paragraph 2(2). Preamble 4 of the draft resolution acknowledges “the linkage between, and mutual supportiveness of, control and elimination of neglected tropical diseases and the global strategy and plan of action on public health, innovation and intellectual property”.
The resolution is silent on the various elements of GSPOA such as prioritizing R&D needs, promoting research and development, building and improving innovative capacity, building innovative capacity, transfer of technology, application and management of intellectual property to contribute to innovation and promote public health, improving delivery and access, and promoting sustainable financing mechanisms.
Thus the more one examines the NTD draft resolution, the agenda of pharmaceutical MNC’s becomes more and more clear. The critical question at this juncture is whether the peoples of South should be given a more comprehensive package to address the burden of NTDs instead of short term solutions like drug donation. While the drug donations would help to address the problem in the short run it does not yield results in the long term. However, it does serve the long term interests of pharmaceutical MNCs to prevent the implementation of new R&D models which address both innovation and access while meeting the unmet R&D needs of developing countries in NTDs.
Observers wonder if Member States will remove the veil and see the real agenda tomorrow when discussion begins.